Robestar

Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) in adults, adolescents & childn ≥6 yr as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. HoFH as adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event as an adjunct to correction of other risk factors.

Hypercholesterolaemia Initially 5 or 10 mg once daily in both statin-naïve or patient switched from another HMG-CoA reductase inhibitor. Dose adjustment to next dose level can be made after 4 wk if necessary. Final titration to max dose of 40 mg should only be considered in patients w/ severe hypercholesterolaemia & high CV risk (particularly those w/ familial hypercholesterolaemia), who do not achieve treatment goal on 20 mg & in whom routine follow-up will be performed. Childn & adolescent 6-17 yr (Tanner Stage <II-V) w/ heterozygous familial hypercholesterolaemia 5-20 mg in childn 10-17 yr & 5-10 mg in childn 6-9 yr. Elderly >70 yr, moderate renal impairment (CrCl <60 mL/min), Asian & patient w/ predisposing factors to myopathy Initially 5 mg. Prevention of CV events 20 mg daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN; myopathy. Concomitant use w/ sofosbuvir/velpatasvir/voxilaprevir; ciclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation. 40-mg dose: Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, moderate renal impairment (CrCl <60 mL/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where increase in plasma levels may occur, Asian patients, concomitant use w/ fibrates.

Discontinue use if CK levels are markedly elevated (>5 x ULN) or muscular symptoms are severe & cause daily discomfort; signs & symptoms suggestive of severe cutaneous adverse reactions (including SJS & DRESS) appear; ILD is suspected to be developed. Do not measure creatinine kinase following strenuous exercise or in presence of a plausible alternative cause of CK increase. Not be used in any patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis in patients particularly w/ >20 mg-dose. Patients who consume excessive quantities of alcohol &/or have history of liver disease; secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Asians. Assess renal function during routine follow-up of patients treated w/ 40-mg dose. Carry out LFTs prior to & 3 mth following initiation of treatment. Clinically & biochemically monitor patients at risk of DM. Not recommended in combination w/ gemfibrozil; PIs. Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid. Dizziness may occur which should be taken into account when driving vehicles or operating machines. Women of childbearing potential should use appropriate contraception. Childn <6 yr.

DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

Plasma conc may be increased & may result in increased risk of myopathy w/ hepatic uptake transporter OATP1B1 & efflux transporter BCRP inhibitors. Increased AUC values w/ ciclosporin. Exposure may be strongly increased w/ PI. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid-lowering doses (≤ 1 g/day) of niacin (nicotinic acid). Increased AUC w/ ezetimibe. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC & C_max w/ erythromycin. Renal excretion may be affected by ticagrelor. May increase INR w/ vit K antagonists eg, warfarin or another coumarin anticoagulant. Increased AUC of ethinyl estradiol & norgestrel & potentially HRT. May increase risk of myopathy including rhabdomyolysis w/ systemic fusidic acid.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx